GXP Journal Articles
Vol. 11, Issue 3, Apr 2007

Jerry Lanese, Ph.D.
For many years, there has been great interest in reducing the burdensome requirements for implementing a change to an approved drug product. This challenge to bring drug product change into the environment of the 21st Century was the topic of a February 7, 2007, Public Meeting, “Supplements and Other Changes to an Approved Application,” held by...
Gordon Welty, Ph.D.
This article reviews the place of task analysis in the process of developing a standard operating procedure (SOP) and the subsequent training module. Task analysis is the process of defining the discrete steps, or tasks that, when executed, will ensure the effective and efficient performance of a job. We look initially at strategic issues and then...
Gabriela Bodea
Corrective and Preventive Action (CAPA), as a subsystem, integrates all quality subsystems, thereby closing a “quality loop.” CAPA represents one of the mechanisms that ensures continuous improvement within an organization; along with customer satisfaction measurements, internal audits, trend recording, and nonconforming product control. Once the...
Gabriela Bodea
When developing a CAPA program, a controlling policy must be in place either as a stand-alone document (policy) or incorporated into the Quality Manual. A policy is a controlled document that typically includes: title, purpose, mission, scope (all quality subsystems that feed into CAPA), and responsibilities. Depending upon the organizational...
Timothy J. Fields
According to the U.S. Food, Drug, and Cosmetic Act (FD&C Act)1 a drug is considered adulterated “if it is a drug and the methods used in, or the facilities or controls used for its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice.”...
When considering the design and building of a pharmaceutical process and a facility to manufacture pharmaceutical products, many of the requirements involved can be found in the U.S. Good Manufacturing Practice (GMP) regulations. The actual specifics will depend upon the product to be produced.
Jerry Lanese, Ph.D.
This article is one of a continuing series in which representatives of Industry and the regulatory agency have an opportunity to express opinions on current GXP issues. Thank you for your responses to Questions 8 and 9 which were posed in the last issue of the Journal of GXP Compliance.